Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 10:52 PM
Study NCT ID:
NCT06698367
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-03
First Post:
2024-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Unilateral Training of the Uninjured Limb on Clinical Outcomes in Patients with Surgically Treated Radius Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Opaque sealed envelopes'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2024-11-18', 'studyFirstSubmitQcDate': '2024-11-18', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Depression, anxiety and stress', 'timeFrame': '0 week', 'description': 'Depression, Anxiety and Stress Scale (0-63 points)'}, {'measure': 'Treatment expectations', 'timeFrame': '0 week', 'description': 'Treatment Expectation Questionnaire (0-10 points)'}, {'measure': 'Physical activity', 'timeFrame': '0 and 12 weeks', 'description': 'International Physical Activity Questionnaire (Categorical Score: Low, Moderate. High)'}], 'primaryOutcomes': [{'measure': 'Handgrip strength', 'timeFrame': '0, 6 and 12 weeks', 'description': 'Jamar grip dynamometer (kilos)'}, {'measure': 'Manual dexterity', 'timeFrame': '0, 6 and 12 weeks', 'description': 'Functional Dexterity Test (Seconds)'}], 'secondaryOutcomes': [{'measure': 'Active range motion', 'timeFrame': '0, 6 and 12 weeks', 'description': 'Wrist and forearm: Extension, flexion, pronation and supination (degree)'}, {'measure': 'Pain intensity', 'timeFrame': '0, 6 and 12 weeks', 'description': 'Visual Analogue Scale (0-10 centimeters)'}, {'measure': 'Forearm circumference', 'timeFrame': '0, 6 and 12 weeks', 'description': 'Circumference (cm)'}, {'measure': 'Maximum voluntary isometric strength.', 'timeFrame': '0, 6 and 12 weeks', 'description': 'Progressor 300, Tindeq, Norway (Kilos)'}, {'measure': 'Self-reported upper limb function.', 'timeFrame': '0, 6 and 12 weeks', 'description': 'Quick Disabilities of Arm, Shoulder and Hand (0-100 points)'}, {'measure': 'Self-reported wrist function', 'timeFrame': '0, 6 and 12 weeks', 'description': 'Patient-Rated Wrist Evaluation (0-50 points)'}, {'measure': 'Health-related quality of life', 'timeFrame': '0, 6 and 12', 'description': 'Short Form-12 (0-100 points)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Distal radius fracture', 'Cross-education', 'Rehabilitation', 'Exercise'], 'conditions': ['Wrist Fractures', 'Distal Radius Fractures']}, 'descriptionModule': {'briefSummary': 'The objective will be to determine the effectiveness of adding unilateral upper limb postoperative training to standard rehabilitation compared to standard rehabilitation on maximum grip strength and manual dexterity in patients aged 30-50 years with surgically treated distal radius fracture. It is presumed that the addition of unilateral upper limb training will significantly improve maximum grip strength and manual dexterity at the end of the intervention period compared to the group receiving only standard rehabilitation.\n\nPatients who agree to participate in this research will be randomly assigned to a control group (standard rehabilitation with unilateral training with mobility exercises) or an experimental group (standard rehabilitation with unilateral high-intensity strength training). The duration of the postoperative intervention will be 12 weeks. The primary variables are maximum grip strength and manual dexterity. Secondary variables are wrist mobility, forearm circumference, maximum voluntary isometric strength, functionality and health-related quality of life. Results will be measured at 0, 6 and 12 weeks postoperative.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 30-50 years\n* Radiological diagnosis of unilateral distal radius fracture without concomitant fractures.\n* Fracture treated surgically.\n\nExclusion Criteria:\n\n* Patients with lesion of the triangular fibrocartilage.\n* Patients with distal radius fracture with consolidation disorders.\n* Patients with health conditions that cause pain or affect the motor skills of the upper limb (radiocarpal osteoarthritis, carpal tunnel syndrome, Quervain's tenosynovitis, neurodegenerative diseases, sequelae of stroke)\n* Patients with multi-site pain or chronic polyarticular diseases such as osteoarthritis or rheumatoid arthritis.\n* Unstable cardiovascular, respiratory, systemic or metabolic conditions that do not allow high-intensity physical exercise.\n* Patients who are taking nutritional supplements that interfere with the regulation of skeletal muscle strength and mass (example: whey protein, creatine, etc.)\n* Inability to understand, read and/or speak the Spanish language."}, 'identificationModule': {'nctId': 'NCT06698367', 'briefTitle': 'Unilateral Training of the Uninjured Limb on Clinical Outcomes in Patients with Surgically Treated Radius Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Catolica de Temuco'}, 'officialTitle': 'Addition of Unilateral Training of the Uninjured Limb to Standard Rehabilitation on Grip Strength and Manual Dexterity of Patients with Surgically Treated Distal Radius Fracture.', 'orgStudyIdInfo': {'id': 'RCT-EdCruzada2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard rehabilitation plus unilateral high-intensity strength exercise', 'description': 'Participants will undergo progressive strength training based on eccentric contractions during the mobilization and strengthening phases of standard rehabilitation.', 'interventionNames': ['Other: Standard rehabilitation', 'Other: Unilateral high-intensity strength exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard rehabilitation plus unilateral mobility exercises', 'description': 'Participants will undergo active mobility training of the pronation-supination movements during the mobilization and strengthening phases of standard rehabilitation', 'interventionNames': ['Other: Standard rehabilitation', 'Other: Unilateral mobility exercises']}], 'interventions': [{'name': 'Standard rehabilitation', 'type': 'OTHER', 'description': 'Protocol based on the best available evidence and to be used in all participants in both groups. The standard rehabilitation protocol will consist of three postoperative phases: Mobilization (0 to 4 weeks), Strengthening (4 to 8 weeks) and Functional phase (8 to 12 weeks). Sessions will be held 3 times a week for 12 weeks. Each session will last 1 hour and will consist of different modalities of therapeutic exercise and cryotherapy.', 'armGroupLabels': ['Standard rehabilitation plus unilateral high-intensity strength exercise', 'Standard rehabilitation plus unilateral mobility exercises']}, {'name': 'Unilateral high-intensity strength exercise', 'type': 'OTHER', 'description': 'Participants will be seated in an armchair with armrests and will perform 4 sets of 8 repetitions of an eccentric exercise for the pronosupinator muscles with a dumbbell with adjustable weights. The training will start with an intensity of 60% of 1RM, until reaching 80% 1RM.', 'armGroupLabels': ['Standard rehabilitation plus unilateral high-intensity strength exercise']}, {'name': 'Unilateral mobility exercises', 'type': 'OTHER', 'description': 'Participants will be seated in an armchair with armrests and will perform 4 sets of 8 repetitions of an active mobility exercise for the pronation-supination muscles using a plastic rod.', 'armGroupLabels': ['Standard rehabilitation plus unilateral mobility exercises']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Temuco', 'state': 'Temuco', 'country': 'Chile', 'contacts': [{'name': 'Iván Cuyul Vásquez', 'role': 'CONTACT', 'email': 'ivancuyul@gmail.com', 'phone': '56990914987'}], 'facility': 'Red Salud', 'geoPoint': {'lat': -38.73628, 'lon': -72.59738}}], 'centralContacts': [{'name': 'Iván Cuyul Vásquez', 'role': 'CONTACT', 'email': 'ivancuyul@gmail.com', 'phone': '56990914987'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Catolica de Temuco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Iván Alejandro Cuyul Vásquez', 'investigatorAffiliation': 'Universidad Catolica de Temuco'}}}}